Overview

Efficacy of Epidiolex in Patients With Electrical Status Epilepticus of Sleep (ESES).

Status:
Recruiting

Trial end date:
2022-10-01

Target enrollment:
0

Participant gender:
All

Summary

This study aims to assess the efficacy of Epidiolex in patients with ESES. ESES is characterized by sleep potentiated spikes with a spike index greater than 85% (conventional definition) and 50% (new definition)1. Several drugs including: steroids, intravenous Gama globulin, Clobazam, other benzodiazepines, Valproic acid, and other anti-epileptic drugs have been tried with mixed benefits2,3. Cannabidiol (CBD) would provide a novel mechanism of action to assess for its efficacy in this population. This will be a double-blind placebo-controlled crossover clinical trial.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Northwell Health

Collaborator:

Greenwich Biosciences

Treatments:

Cannabidiol
Epidiolex

Criteria

In order to be eligible to participate in this study, an individual must meet all of the
following criteria:

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the
duration of the study

3. Male or female, aged 2-17 years old

4. In good general health as evidenced by medical history or diagnosed with ESES

5. Ability to take oral medication and be willing to adhere to the Epidiolex/Placebo
regimen

6. For females of reproductive potential: use of highly effective contraception for at
least 1 month prior to screening and agreement to use such a method during study
participation and for an additional 1 month after the end of oral Epidiolex
administration

7. For males of reproductive potential: use of condoms or other methods to ensure
effective contraception with partner

Exclusion Criteria:An individual who meets any of the following criteria will be excluded
from participation in this study:

1. Previous use of cannabidiol within 4 months.

2. Pregnancy or lactation

3. Known allergic reactions to components of the Epidiolex: cannabidiol, sesame seed oil,
and sucralose

4. Febrile illness within 1 month of screening

5. Treatment with another investigational drug or other intervention within 6 months

6. Current smoker or tobacco use within 6 months